FDA 510(k) Application Details - K983483

Device Classification Name Device, Neurovascular Embolization

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510(K) Number K983483
Device Name Device, Neurovascular Embolization
Applicant CORDIS NEUROVASCULAR, INC.
14000 N.W. 57TH CT.
MIAMI LAKES, FL 33014 US
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Contact MARTINE D SCHNEIDER
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Regulation Number 882.5950

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Classification Product Code HCG
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Date Received 10/05/1998
Decision Date 03/24/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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